A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: AstraZeneca, Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control

• Drug naive or treated with anti-diabetic medication for < 24 weeks

• C-peptide ≥ 1.0 ng/mL

• Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

• AST and/or ALT > 3 times ULN

• Serum total bilirubin > 2 mg/dL

• Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women

• Creatine kinase ≥ 3 times ULN

• Symptoms of severely uncontrolled diabetes

• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases